NCT02004782: BERST

Barretts oEsophageal Resection With Steroid Therapy Trial

Withdrawn Phase 4 Last updated 27 March 2025

What this trial tests

Phase 4 trial testing Prednisolone in Barrett Esophagus. Withdrawn.

Timeline

9 March 2020

Primary endpoint
9 March 2020

9 March 2020

Quick facts

Lead sponsor	Professor Michael Bourke
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Start date	9 March 2020
Primary completion	9 March 2020
Estimated completion	9 March 2020
Sites	1 location across Australia

Drugs / interventions tested

• Prednisolone — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Barrett Esophagus — all drugs for Barrett Esophagus →
• Esophageal Stenosis — all drugs for Esophageal Stenosis →

Sponsor

Professor Michael Bourke

Who can join

Adults 18 to 90, any sex, with Barrett Esophagus or Esophageal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer. Oesophageal cancer is aggressive, with a 5 year survival of only \~15%. High risk Barretts mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they have premalignant or early malignant disease, it is a curative procedure.

Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue development in the oesophagus, leading to stricture formation and difficulty swallowing (dysphagia). If a safe and effective method could be found to reduce this risk, the treatment options for early oesophageal cancer would be greatly improved. CBE is performed as a two stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study, eligible and enrolled patients are randomised after the 1st stage CBE to receive either prednisolone tablets or placebo. Inclusion criteria are patients with short segment (\<3cm circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing dose over the 6 weeks, starting at 40mg daily.

The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be performed as required for dysphagia secondary to symptomatic oesophageal stricture formation persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to assess for complete removal of Barretts mucosa.

Following two stage CBE, stricture rates without preemptive therapy in noncircumferential, circumferential \<2cm, and circumferential \<3cm disease, are estimated to be 30%, 50% and 70% respectively. The investigators predict a 50% reduction in stricture rate with oral steroid therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop out rate, a total of 126 patients are required. The study will be performed at five Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.